This Information Paper aims to explain in a simple and informative way 'What areNovel Food Requirements for Algae?' and how we can answer to the most relevantquestions that are brought by the different players that interact with 'algae', including:academia, industry, trade organizations, consumers, business investors, - local,national authorities, international oganizations and any other interested parts orstakeholders. This Position Paper represents the position of EABA as the Algae Biomasssector Association and brings toghether existing information from the science,technology and business levels impacted by 'algae' biomass.
The European Algae Biomass Association (EABA) was established in Florence in June 2009 as the European association representing both research and industry in the field of algal technologies. EABA is representing both macro- and microalgae biomass interested organizations and individuals.
The general objective of EABA is to promote mutual interaction and cooperation in the field of algae biomass production, transformation and use for the whole range of algae applications. It aims at creating, developing, promoting and maintaining solidarity, contact, interaction and collaboration among its members and at defending their scientific and commercial interests at the European and international level. Its main target is to act as a catalyst for fostering synergies among scientists, industrialists and decision makers in order to promote the development of research, technology and industrial capacities in the field of algology.
The Association is technology neutral and does not aim at favouring a particular kind of production, processing or use of the algae biomass or biotechnology. This approach reflects the fact that all production technologies and uses of algae biomass or related services are to be considered as interdependent. With these aims in mind, the Members of EABA share with each other accurate non-confidential information about the algae biomass sector (adapted from EABA STATUTES).
Algae, including microalgae and seaweeds have a long history andincreasingly important applications as both food ingredients andanimal feed, but also for other raw materials such constituents ofcosmetics, agrochemicals, biomaterials and as renewable bioenergyfeedstocks. The vast majority of algal species have yet to beevaluated for these applications. However, due to their extensivediversity, it is likely that they will lead to the discovery of manynew algal products and processes in the future.
Most companies tend to expand by producing new products andaddressing new markets. However, this must be done strictly incompliance with the relevant regulation. The one applied to foodstuffin Europe aims to ensure food safety, whatever the origin ofthe primary matter, including algae. Algae are a new frontier withhigh potential as alternative food sources/ingredients as their explorationreveals products with numerous virtues, especially forhealth and welfare. The paradox is that their biodiversity, whichis probably the richest of the biosphere, is nearly untapped withonly a handful of species authorized to be put on the market accordingto EU food law. With few exceptions, algae are considereda “Novel Foods” (NF) and as such subject to safety assessments.
At present the time and money required to obtain the allowanceof marketing a new species and its extracts is such that a simplificationof the regulation is expected.
Regulation n. 258/97 of the European Parliament and the Councilsets out the legal framework for the marketing of “Novel Foods”.Aiming at granting a high level of consumer protection and thefunctioning of the internal market, the Regulation provides a systemof authorization for the marketing of novel foods. However,the application of these rules highlights the critical issues of thesystem, such as the ambiguities of the notions, the slowness of theprocedures (on the average 3 years.) and the high costs to obtainNF permission (€200,000 to €400,000). These problems, togetherwith the development of the modern technologies, have determinedthe need for a reform.
On 25 November 2015, the European Parliament and the Counciladopted the Regulation (EU 2015/2283) of the European Parliamentand of the Council on Novel Foods which repealed Regulation(EC) No 258/97. The Regulation requires that all applicationsfor the authorization of novel foods shall be submitted to theCommission who may then request a risk assessment from theEuropean Food Safety Authority (EFSA). In the context of this document,food consisting of, isolated or produced from algae or froman algae cell culture will be novel food if it has not been consumedto a significant degree within the Union before May 15, 1997.
A food business operator who wants to bring a food to the EU markethas the responsibility to assess and determine its novel foodstatus based on the evidence available to them. If they cannot decideon the novel food status of their food, they may consult theauthorities in the Member State in which they intend to first placethe food on the market according to the provisions of Article 4 ofthe Novel Food Regulation (EU) 2015/2283 and the provisions ofCommission Implementing Regulation (EU) 2018/456. In this process,the potential applicant can submit a consultation requestelectronically to a competent authority of a Member State thatcomprises the following: (a) a cover letter; (b) a technical dossier;(c) supporting documentation; (d) an explanatory note clarifyingthe purpose and relevance of the submitted documentation (seeCOMMISSION IMPLEMENTING REGULATION (EU) 2018/456).
The decision whether a food constitutes a novel food or not is takenby the Member State that received the request. The decision toconclude the food is a novel food is done on a case by case. Even ifthe product is very similar to a product already on the market, if itis produced by or with an algae species that was not used for thispurpose before, it may be considered as a novel food. Supportingdocumentation; The outcome of the decision (Yes, No, FS, ?) ispublished by EU in the Novel Food Catalog (NFC)
As a similar example, recently (Early in 2018) European Commissioninvestigation showed that many companies are sellingnon-authorised Novel Foods and food supplements with medicinalclaims. Especially the ones marketed through the Internet,where two thirds of the online traders placed in the market unauthorisedfoods. Authorities checked nearly 1.100 websites andfound 779 non-compliant offers. This was made up of 428 offersof unauthorized novel foods and 351 food supplements with unauthorized/false medical claims. The 25 member states as well asNorway and Switzerland which took part in the first EU coordinatedcontrol plan on online offered food products orchestrated bythe European Commission.
https://ec.europa.eu/food/sites/food/files/oc_oof_analysis_main_outcome_en.pdf
The high number of non-compliant offers is a clear sign thate-commerce control across Europe needs to be strengthened.Whether purchasing from a physical store or online, consumershave the right to buy safe food which does not mislead. It is expectedthat controls and investigations will increase in the nearfuture and will imply penalties and market restrictions.
Today, although concrete evidence is not available, there may bealgae products in the EU market (both online and offline stores)for which the novel food status has not been established. Nannochloropsisgaditana microalgae species is such an example andof course there could be others. The Algae sector as a new emergingsector should carefully ensure compliance with the Novel foodRegulation. Lack of controls and penalties may lead to an increasingfraudulent activity.
The notion of “Novel Foods” is not new. Throughout history newtypes of food, food ingredients or ways of producing food havefound their way to Europe from all corners of the globe. Bananas,tomatoes, tropical fruit, maize, rice, a wide range of spices – alloriginally came to Europe as novel foods. Among the recent arrivalsare chia seeds, algae-based foods, Baobab fruit and insects.
According to the new “Novel Foods” Regulation (EU) 2015/2283of the European Parliament and of the Council (European Union,2015a), replacing Regulation (EC) No. 258/97 (European Union,1997) of the European Parliament and of the Council:
“Novel Food means any food that was not used for humanconsumption to a significant degree within the EU before15 May 1997 (when the first Regulation n° 258/97 on novelfood came into force) irrespective of the dates of accession ofmember states to the Union”
According to the new Regulation which will come into effect inJanuary 2018, Novel Foods fall within at least one of the categorieslisted in Article 3 (for more detail see Annex 1):
Novel Foods Regulation does not apply to:
Novel Food refers to new food sources or newly developed andinnovative food, food produced using new technologies and productionprocesses, and food traditionally consumed in countriesoutside the EU, but not within the EU. These “traditional food fromthird countries” include foods made from plants, microorganisms,fungi, algae and animals.
In Europe, algae (macro and micro) are considered NF. They canbe used as food if put on market as food or food ingredient andconsumed to a significant degree before May 15, 1997. Up to day,11 macroalgal and 5 microalgal species are authorized as food orfood ingredient and listed as “not novel” (or old) in the EU NovelFood Catalogue (Table 1). In France since 1990, some other speciesof seaweed have been authorized for food consumption. Francewas one the first European country to establish a specific regulationconcerning the use of seaweeds for human consumption asnon–traditional food substances (Centre d’Etudes et de Valorisationdes Algues, CEVA, 2014).
The microalgae used prior to May 1997 in Europe and thus authorizedas food in the EU are Aphanizomenon flos-aquae fromKlamath Lake, Arthrospira platensis, Chlorella luteoviridis, Chlorellapyrenoidosa, and Chlorella vulgaris and an undefined "Spirulina sp."(European Union, NovelFood catalogue). The diatom Odontella aurita was authorized in2005 (European Union, 2005), and, in 2009, DHA-rich oil from Ulkeniasp. has been approved as novel food ingredient (EuropeanUnion, 2009). In 2014, Tetraselmis chuii and astaxanthin from Haematococcuspluvialis have been approved as food (AECOSAN 2014;EFSA 2014). In 2015, oil from Schizochytrium sp. was also authorized(European Union, 2015b,c).
The European Novel Foods Catalogue is an informal and non-exhaustivetool listing products of animal and plant origin and othersubstances that are subject or not to the novel food regulation. Itis based on information regarding history of consumption of theseproducts in the EU. The catalogue has no legal value for producersand importers seeking to market the substances and ingredientsincluded in the catalogue. A non–European exporter would havea very difficult time determining which novel foods or substances are authorized, since some Member States may further restrict themarketing of a novel food through specific legislation.
Novel foods need permission to be marketed in Europe. They needto be safe for consumers and properly labelled as to identify themas novel to the consumer. Authorization and use of novel foodsand food ingredients have been harmonized in the EuropeanUnion since 1997 when Regulation 258/1997 (European Union,1997) on novel foods and novel food ingredients was adopted. In2013, the EU Commission presented a proposal for a new Regulationand in November 2015 the European Parliament and theCouncil have reached an agreement with the new Regulation EU2015/2283 (European Union, 2015).
Fig.1. Novel Food market placing.
TYPE | GROUP | SCIENTIFIC NAME | COMMON NAME | NOTES |
---|---|---|---|---|
MACROALGAE (SEAWEEDS) | Brown | Ascophyllum nodosum | In EU NF catalogue | |
Eisenia bicyclis | In EU NF catalogue | |||
Fucus vesiculosus | In EU NF catalogue | |||
Hizikia fusiforme | “ | |||
Laminaria digitata | Kombu | “ | ||
Laminaria longicruris | Kelp | “ | ||
Saccharina latissima (formerly Laminaria saccharina) | Royal Kombu | “ | ||
Saccharina japonica (formerly Laminaria japonica) | Royal Kombu | “ | ||
Undaria pinnatifida | Wakame | “ | ||
Himanthalia elongata | Sea spaghetti | In EU NF Catalogue | ||
Alaria esculenta | Atlantic wakame | In EU NF Catalogue | ||
Red | Palmaria palmata (Rhodymenia palmata) | Dulse | In EU NF catalogue | |
Porphyra tenera | Nori | In EU NF Catalogue | ||
Porphyra umbilicalis | “ | French authorization | ||
Porphyra yezoensis | “ | “ | ||
Porphyra dioica | “ | “ | ||
Porphyra purpurea | “ | “ | ||
Porphyra laciniata | “ | “ | ||
Porphyra leucostica | “ | “ | ||
Chondrus crispus | Pioca, lichen | In EU NF Catalogue | ||
Gracilaria verrucosa | Ogonori | In EU NF Catalogue | ||
Lithothamnium calcareum | Mäerl | In EU NF Catalogue | ||
Green | Ulva sp. | Sea lettuce | In EU NF Catalogue | |
Enteromorpha sp. | Aonori | In EU NF Catalogue | ||
MICROALGAE | Aphanizomenon flos-aquae | Alga Klamat | In EU NF catalogue | |
Arthrospira platensis | Spirulina | “ | ||
Chlorella luteoviridis | “ | |||
Chlorella pyrenoidosa | “ | |||
Chlorella vulgaris | “ |
Table 1. Algae used prior to 15th of May 1997 listed as “not novel” in the EU Novel Foods Catalogue.
They do not require authorization under the Novel Foods Regulation. Additional macroalgae authorized in France before 1997 are also shown.
Fig.2. Simplified diagrams of the two NF regulation procedures, the old one that refers to Regulation EC 258/97, was valid until 31
December 2017, the new one is based on the Regulation EU2015/2283 and is in force since 1 January 2018.
According to new Regulation an applicant who intends to placeon the EU market a novel foods should submit an application tothe European Commission that, after having verified its validity(1 month), will make it available to the Member States and givemandate to European Food Safety Authority (EFSA) for a safety assessment.EFSA shall adopt its opinion within 9 months from thedate of receipt of a valid application from the EC. Within 7 monthsfrom the date of publication of EFSA’s opinion, the Commissionmust submit a draft proposal authorizing the novel food to theStanding Committee on Plants, Animals, Food and Feed (PAFF). Ifno EFSA opinion is requested, the 7-month period starts from thedate on which the Commission receives a valid application.The main changes of the new regulation are:
The procedure for safety assessment for traditional foods fromthird countries, is based on a history of safe food use. It meansthat the safety of the food in question has been confirmed withcompositional data and from experience of continued use for atleast 25 years in the customary diet of a significant number ofpeople in at least one third country. The history of safe food useshould not include non-food uses or uses not related to normaldiets.
If the traditional food in question can historically be demonstratedto be safe, and no safety concerns are raised by EU Member Statesor EFSA, that traditional food may be placed on the market on thebasis of a notification from the applicant. A Member State or EFSAmay submit duly reasoned safety objections on the placing on themarket of the notified food. In this latter case, the applicant maytransform the notification into an application, for which a safety evaluation will be requested from EFSA. In assessing the safety of these types of novel foods, EFSA shall consider the following:
On 10 November 2016, EFSA published two guidance documentson novel food and on traditional food following the new Europeanregulation on novel food (EFSA, 2016a,b). EFSA new guidance documentsexplain in detail the kind of information applicants needto provide when a risk assessment is required and how to presentthis information to EFSA.
Article 6 of Regulation 2015/2283 requires the Commission to establishan EU list of authorized novel foods by January 1, 2018.The list will initially include novel foods that have already beenauthorized under Regulation 258/97. The list would also include,where appropriate, the conditions of use, additional labeling requirementsand post-market monitoring requirements. In thecase of authorized traditional foods, the entry in the union listshall specify that it concerns of traditional food from a third country.The list will be available (completed) by 1 January 2018 andregularly updated. An Union Draft List of novel foods authorizedor notified under Regulation (EC) No 258/97 has been to publishedat the beginning of October, 2017 (Ref. Ares (2017) 4851094- 04/10/2017 https://ec.europa.eu/info/law/better-regulation/initiatives/ares-2017-4851094_en). The Union list shall consist ofTables 1 (Authorized NF) and 2 (Specifications). The Annex 2 showsmicroalgae authorized to be marketed in EU as currently reportedin the Union List.
As a general rule, authorizations will be generic. Under the newregulation there are two options:
The "initial applicant" has the faculty to ask that scientific evidenceor scientific data presented in support of the applicationfor authorization, cannot - without his consent - be used for thebenefit of a subsequent application within non-renewable 5-yearperiod from the date of authorization and if the data are eligiblefor protection. The criteria for eligibility are as follows:
The new EU Regulation delivers:
The purpose of a risk assessment for a novel food is to evaluateits potential impact on public health and safety status. During theevaluation of the public health and safety of a novel food, a varietyof toxicological and nutritional issues have to be considered togetherwith information on its chemistry and the amount of people expected to eat it. In assessing the safety of novel foods under the Regulation2015/2283, EFSA shall consider the following:
Consumption of any food is not without risk, so the promotion ofalgal consumption must also consider potential harm to consumers.Possible risks associated with algae include excess intake oftoxic metals, allergenicity, cyanotoxins, and certainly secondarymetabolites as well as contamination with pathogens, radioisotopes,and toxic synthetic compounds (Wells et al., 2017).
New nutrient sources are needed to face the challenges that areputting food security under great stress. The crushing weight ofthe world’s population, projected to soar up to 10 billion by 2050,will inevitably result in an increased demand for food. Animal proteinsaccount for about 40% of global protein consumption, buttheir production is highly inefficient, with about 2 to 15 kg of plantmaterial being required for 1 kg of animal products. Furthermore,cattle breeding and meat consumption are associated with a highenvironmental footprint and greenhouse gas release, thus makingthese practices unsustainable.
It becomes imperative to find innovative nutrient sources for a“Sustainable, Safe and Nutritious Food” of the future. One of themost promising alternatives to animal proteins for both humanconsumption and feed applications are algae. Alternative proteinsare estimated to make up 33% (i.e. 310 million metric tonnes) ofglobal protein consumption by 2054, with algae accounting forabout 18%.
The most common varieties of edible seaweed that include Nori,Wakame, Kombu, Dulse and Carrageen, are associated with manyhealth benefits, including lowering blood pressure and preventingstrokes, but most importantly, they are a valuable source ofprotein minerals and vitamins, not to mention their negligible fatand cholesterol content. On the other hand, microalgae positivelyaffect humans and animal health due to their original chemicalcomposition, namely high protein content, with balanced aminoacids pattern, carotenoids, fatty acids, vitamins, polysaccharides,sterols, phycobilins and other biologically active compounds.
From a public health perspective, new sources of nutrients couldhelp ensure food security and decrease the incidence of cardiovasculardiseases related to unhealthy food. The diffusion of newnutrient sources is supported by their numerous social and environmentalbenefits, which contribute to their public acceptanceand future uptake. However, several obstacles are faced by companiestrying to promote their production and commercialization.These include cultural barriers affecting customer acceptance, therestrictive EU regulatory environment as well as production andscaling-up costs.
Data in Table 2 refer to global microalgae production, with the currently contribution of the EU quite limited. It was estimated the EU production share at around 5% of the global figures in Table 2.
MICROALGAE-BASED PRODUCT | PRODUCTION VOLUME (TONS/YEAR DRY WEIGHT) | NUMBER OF PRODUCERS | PRODUCTION VALUE (ANUAL TURNOVER, MIO US $) | PRODUCTION VALUE OF ALTERNATIVE SOURCES (ANNUAL TURNOVER, MIO US $) |
---|---|---|---|---|
Whole-dryed micro-algae | ||||
Spirulina | 5000 (2012) ᵃ | 15 | 40 (2015) ᵇ | No alternative |
Chlorella | 2000 (2003) ᵃ | 70 | 38 (2006) ᶜ | No alternative |
High-value molecules | ||||
Astaxanthin | 300 (2004) ᵃ | 8 | 10 (2004) ᶜ | 200 (2004) ᵇ |
Phycobiliprotein (incl. phycocyanin) | (NA) | 2 | (NA) | 50 (2004) ᵇ |
Omega-2 fatty acids | 240 (2003) ᵇ | 4 | 300 (2004) ᵇ | 14390 (2009) ᵈ |
Beta-Carotene | 1200 (2010) ᶜ | 10 | (NA) | 285 (2012) ᵇ |
Table 2. Market Figures of Micro-Algae based products.
Note: In brackets the year of which the estimation was done.
ᵃ Norser et al., 2011; ᵇ Millege, 2012; ᶜ Spolaore et al., 2016; ᵈ Ismail, 2010.
Source: Enzing et al., 2014. Reproduction is authorized provided the source is acknowledged.
The actual production capacity is closely related to human applications,estimated around 10.000 t/year. Regarding market price, theactual microalgae biomass production cost ranges from minimum5 €/kg in raceway ponds to 50 €/kg in photobioreactors; the marketvalue of human-related products exceeds 103 M€/ year.Microalgae biomass contains proteins, lipids, and carbohydrates,all of them of high quality for human consumption. Thus, microalgaebiomass contains large amounts of essential amino acids and polyunsaturated fatty acids, in addition to sterols and carotenoidswith antioxidant activity, thus this biomass being considered as asuperfood. Microalgae have been reported to be a “sustainable”source of food and nutraceuticals for human uses, by its highernutritional and functional properties versus conventional crops ascereals and vegetables and its lower land requirement also reducingthe risks related to food insecurity supply in the world.
Microalgae biomass can be used as food directly, in different mixtures with other foods, or alternatively by consuming extractsof valuable compounds. Dry biomass of Chlorella and Spirulinais commercialized as powder or in capsules, also it being incorporatedto juices, cakes, pasta, and other foods to enhance thenutritional value or provide healthy properties as antioxidant,among others. Regarding extracts, carotenoids as astaxanthinand ß-carotene are extracted from the biomass of Haematococcusand Dunaliella, and incorporated to suspension as healthenhancer.
Other compounds as polyunsaturated fatty acids, i.e.,eicosapentaenoic cid (EPA), arachidonic acid (AA), and docosahexaenoicacid (DHA), are also extracted mainly from the biomass ofmarine strains, as Nannochloropsis and T-ISO, also mainly usingsupercritical CO2, and incorporated to oils and capsules for humanconsumption. Special mention is the case of the productionof docosahexaenoic acid (DHA) from Schizochytrium that is incorporatedto infant milks in a high-value application (Enzing et al.2014; Vigani et al., 2015).
Major concern about the incorporation of microalgae biomass tofoods is related to EU regulation. In spite of largely reported advantagesof microalgae biomass for human consumption, onlythe microalgae now generally recognized as safe (GRAS) can besold for human consumption. These only include Chlorella, Spirulina,Dunaliella, and Haematococcus. Other microalgae must beregistered as novel food. Anyway, independent of the strain to beproduced, the overall production system must be approved for“food industry”; this certification involves the materials, systems,and protocols used during the production process. In this way, theinvolvement of food companies in the development of microalgae-based processes is mandatory.
Although “novel foods” are not defined in the United States,any new food ingredient is considered either as a food additive(requiring a pre-market approval by the U.S. Food and DrugAdministration (FDA)) or are Generally Recognized as Safe(GRAS) for specific uses, which can be determined by consensusof a panel of qualified experts. Substances that are GRAS underconditions of their intended use are not food additives and do notrequire premarket approval by FDA. Thus, for a food additive, FDAdetermines the safety of the ingredient; whereas a determinationthat an ingredient is GRAS can be made by qualified expertsoutside of government. While GRAS notifications to the FDA arevoluntary, a “no questions” response from FDA provides additionalassurances of the regulatory status to end users of the ingredientand is useful in importing ingredients manufactured outside ofthe U.S. Typically, new (novel) food ingredients undergo a GRASdetermination (FDA, 2014).
According to the classification of the Center for Food Safety andApplied Nutrition, algal biomass is classified as “other dietarysupplement”. Spirulina, Chlorella, Dunaliella, Haematococcus,Schizochytrium, Phorphyridium cruentum and Crypthecodiniumcohnii are classified as food sources falling into the GRAS. Otherproducts derived from microalgae classified by FDA as GRAS are oils obtained from Schizochytrium and Ulkenia, as well as a wholemicroalgal protein powder and a lipid ingredient derived fromChlorella (http://www.accessdata.fda.gov/scripts/fcn/fcnnavigation.cfm?rpt=eafuslisting).
As there is no legal distinction between “new” and other foodsin the United States, U.S. exporters should always check withtheir EU importers, who are responsible for putting products thatcomply with EU legislation on the EU market, whether a novelfood authorization may be needed.
In addition to the USA, other extra-European countries have specificregulations. For instance, Food Standards Australia NewZealand (FSANZ) regulates the use of novel food ingredients, suchas products from microalgae. The FSANZ considers as novel foodall non-traditional food or its derivatives and requires safety assessment.Novel foods and novel food ingredients are regulatedunder Standard 1.5.1 – Novel Foods in the Food Standards Code(https://www.legislation.gov.au/Details/F2017C00324).
A novel food cannot be sold as food or used as a food ingredientunless it is listed in the Standard.
Anyone wanting to sell a novel food or a novel food ingredientmust apply to FSANZ to request that the Standard be amended toinclude the food or ingredient in the list. Novel food applicationsare subject to a pre-market safety assessment. If the food passesthis assessment, it is added to the list in the Standard and themanufacturer can go ahead and sell it, as long as it complies withany specified conditions. According to the Food Standard Code,they have granted permission for using Schizochytrium as a driedmarine microalga, which is rich in omega-3 long-chain polyunsaturatedfatty acid (DHA), as a novel food ingredient in a limitedrange of foods.
In Canada, under the Food and Drugs Act and Regulations, novelfoods are defined as foods/ingredients without a history of safeuse as a food in Canada, are produced via novel processes, or havebeen modified by genetic manipulation. These novel foods requirea pre-market assessment by Health Canada prior to being put onthe market. Health Canada is advising consumers to apply cautionwhen using non Spirulina cyanobacterial products. In addition, itdoes not allow therapeutic claims for substances sold as foods.
The EU, USA and Canada have broadly similar approaches toAustralia and New Zealand in the regulation of novel foods, insofaras some form of pre-market safety assessment is required beforethese foods can be sold to consumers. However, the identificationof these foods, the form of pre-market assessment, the level ofregulatory oversight and the legislated powers of regulators does vary between countries. FSANZ has highlighted aspects from theinternational approaches that may be of assistance in improvingthe regulation of novel foods in Australia and New Zealand.In particular:
The regulation of novel food and ingredients in China areregulated according to the Administrative Measures for SafetyReview of New Food Materials (2013). Novel foods, under thenew regulation becomes “new food raw material” – encompassanimal, plant, or micro-organisms or substances derived fromthese sources, food substances with structural changes, ornewly developed food materials. Pre-market approval of novelfood materials is conducted by the National Health and FamilyPlanning Commission (NHFPC).
Similarly to EU, China has established a comparable systemto regulate novel foods, which takes into account the specificsituation in China where novel food material and health food areclosely linked, given that certain traditional materials can be usedfor both food and medicine. In light of this, the general evolution of novel foods regulation in China is related to the development ofthe food industry and the longstanding food culture.(Sun, 2015; https://food.chemlinked.com/node/2818).
Despite microalgae are considered a potential source of functionalfoods and nutraceuticals thanks to their valuable and balancedbiochemical composition, their use as food /food ingredientsis still poorly developed in EU due to high production cost, lowdemand and strict legislation. As repeatedly noted, the approvedmicroalgae (and microalgal products) in EU represent a verysmall number of species compared to the high number present innature (Guiry, 2012). Other species than those reported in Table 3could be suitable ingredients in innovative functional foods andas nutraceuticals.
ALGAE | YEAR OF EU APPROVAL AS FOOD |
---|---|
Arthrospira platensis (spirulina) | Used prior to May 1997 |
Chlorella luteoviridis | Used prior to May 1997 |
Chlorella pyrenoidosa | Used prior to May 1997 |
Chlorella vulgaris | Used prior to May 1997 |
Aphanizomenon flos-aquae | Used prior to May 1997 |
Odontella aurita | 2005 |
Ulkenia sp. | 2009 |
Tetraselmis chuii | 2014 |
Haematococcus pluvialis | 2014 |
Schizochytrium sp. | 2015 |
Table 3. Microalgae approved for food use in EU.
In this section we want to highlight why other microalgal speciesand species currently produced in Europe but sold elsewhere andtheir bioactive constituents should be permitted for sale withinthe EU. This for the benefit of European producers and consumers,the European economy and the quality of microalgal production and products. Table 4 intended to be a non-exhaustive proposal of new microalgae species and products to be introduced in theEuropean food.
MICROALGAE | BIOACTIVE COMPOUNDS |
---|---|
Arthrospira maxima * | Protein, Peptides, Phycocyanin, GLA |
Chlorella protothecoides | |
Dunaliella salina | |
Dunaliella sp. | ß-carotene, Lipids |
Euglena viridis | |
Isochrysis sp. | DHA, Fucoxanthin, Phytosterols, Lipids |
Nannochloropsis sp. | EPA, ARA, Lipids |
Pavlova lutheri | DHA+EPA, Fucoxanthin, Phytosterols,Lipids |
Phaeodactylum tricornutum | EPA, Fucoxanthin, ß-glucan |
Porphyridium purpureum | Polysaccharides, Phycoerythrin |
Scenedesmus almeriensis | Lutein |
Tetraselmis suecica | Protein, Vit. E |
Trachydiscus sp. | EPA |
Table 4. Proposed new algal species to be introduced in EU.
* only A. platensis is now accepted in EU. A. maxima, most widely distributed inCentral America, was harvested from Texcoco lake and used as food. Its biochemicalcomposition has been extensively investigated, showing similar nutritional profile.Moreover, in the 1970s and 1980s Sosa Texcoco Co. cultivated A. maxima in ElCaracol in Lake Texcoco near Mexico City. So, it could be assimilated to “Traditionalfoods from third countries”
The starting point for future development of algae-basedfood ingredients and nutraceuticals is an accurate selectionof the most suitable algal species, the evaluation of theirbiochemical composition, toxicity, digestibility and nutrientbioavailability for humans. Nutritional composition across algalspecies, strictly depends by geographical regions, seasons,and analytical procedures adopted. It is necessary to define anumber of parameters to be evaluated and to develop standardmethods (STANDARDS) for their determination. Digestion andbioavailability of algae matrices are currently little known andfurther insights and improvements are required (Batista et al.,2017; Wells et al., 2017).
The application dossier should provide all of the available(proprietary, confidential and published) scientific data (includingboth data in favor and not in favor) that are pertinent to thesafety of the novel food produced by or with strain of algae. Datapertinent to the safety of the novel food should be generated andstudies performed and documented in order to demonstrate thatthe application covers the totality of information available on thenovel food on which a conclusion on the safety of the novel foodshould be based.
Information on the literature search strategy, including the sourcesused to retrieve pertinent data (databases, other sources), theterms and limits used (e.g. publication dates, publication types,languages, population) should be provided. Where applicable, thepublished literature should be reviewed by taking into accountsystematic review principles (EFSA, 2010). Full study reportsshould be provided if available.
To help the applicant to put a dossier for authorization of a novelfood together, the Commission has put a website on the internetthat can be used to electronically submit applications (https://ec.europa.eu/food/sites/food/files/safety/docs/fs_novel-food_e-submission-system_user-guide_en.pdf). EFSA has published anadministrative guidance on the submission of applications forauthorisation of a novel food pursuant to Article 10 of Regulation(EU) 2015/2283 (2018), in addition to a Guidance Document thatspells out the information requirement for evaluation of the novelfood dossier (EFSA, Panel on Nutrition, Dietetic Products andAllergies (NDA) et al., 2016.
Adherence to the format of the EFSA guidance will facilitateeasy access to information and scientific data in applicationsto help the NDA Panel of EFSA to carry out its evaluation and todeliver its scientific opinion in an effective and consistent way.The information requirements relate to the description of thenovel food, the production process, the compositional data,the stability of the novel food over time, the specification, theproposed uses and use levels, and the anticipated intake of thenovel food. Further sections on the history of use of the novel foodand/or its source, absorption, distribution, metabolism, excretion,nutritional information, toxicological information, informationon studies in humans and allergenicity should be considered bythe applicant by default. If any of these aspects are not coveredin the application, the reason for this should be given and the rationale how to come to a conclusion on the safety of the novelfood without that specific information should be justified by theapplicant.
The applicant should integrate all the data presented in thedifferent sections to provide their overall considerations on howthe information supports the safety of the novel food under theproposed conditions of use. Where potential health hazards havebeen identified (e.g. on the basis of the composition of the novelfood, its production process, its history of use, results from animalor human studies), they should be discussed in relation to theanticipated intakes of the novel food and the proposed targetpopulations. A thorough estimation of the anticipated intake, andof the combined intake from the novel food and other sources, isan important piece of information to conclude on where or not afood would pose the target population at risk under the proposedconditions of use.
The questions that need to be answered are the following: whetherthe composition of the novel food and the conditions of its usedo not pose a safety risk to human health in the Union; whetherthe novel food concerned is as safe as food from a comparablefood category already existing on the market within the Union;and whether a novel food, which is intended to replace anotherfood, does not differ from that food in such a way that its normalconsumption would be nutritionally disadvantageous for theconsumer.
To help the applicant submit a dossier for traditional foods, EFSAhas published a guidance on the preparation and presentation ofthe notification and application for authorisation of traditionalfoods from third countries (NDA et al., 2016). The information thatis required for this evaluation comprises compositional data, andexperience of continued use for at least 25 years in the customarydiet of a significant number of people in at least one third countryintake from the novel food and other sources, is an importantpiece of information to conclude on where or not a food wouldpose the target population at risk under the proposed conditionsof use.
The questions that need to be answered are the following: whetherthe composition of the novel food and the conditions of its usedo not pose a safety risk to human health in the Union; whetherthe novel food concerned is as safe as food from a comparablefood category already existing on the market within the Union;and whether a novel food, which is intended to replace anotherfood, does not differ from that food in such a way that its normalconsumption would be nutritionally disadvantageous for theconsumer.
To help the applicant submit a dossier for traditional foods, EFSAhas published a guidance on the preparation and presentation ofthe notification and application for authorisation of traditionalfoods from third countries (NDA et al., 2016). The informationthat is required for this evaluation comprises compositionaldata, and experience of continued use for at least 25 years in thecustomary diet of a significant number of people in at least onethird country been rejected, the reasons why should be indicated, and a rationale why these reasons would not apply to the newapplication for authorization in the EU should be given.
In order to conclude on the safety of a novel food, a clearestimation of the anticipated intake under the conditions of useis crucial for prediction of the anticipated intake, preferentiallyEU wide data bases are used, rather than national databases. Incase a national data base is used, the reason for this should bejustified, while in addition a rationale should be provided why thecalculations would be of relevance for the European population.
Within EFSA there is the Comprehensive Food consumptionDatabase can be used; summary statistics of food consumptionare available on the EFSA website in the form of spreadsheets.Detailed information on the database and guidance on its usehave been published by EFSA (EFSA, 2011). Anticipated dailyintakes for mean and high-percentile consumers can be calculatedthrough the combination of the intended use level in each foodcategory with mean and high chronic consumption values fromthe database, respectively.
The use of the EFSA Food Additive Intake Model (FAIM) tool (which isalso based on summary statistics of the EFSA Comprehensive FoodConsumption Database) may serve as an appropriate alternative.The FAIM tool was developed to support the calculation of chronicexposure to food additives in the regulatory framework of foodadditives Regulation (EU) 1333/2008.
Exposure assessment of food additives and intake assessmentof novel food ingredients share common principles. Thus, theFAIM tool may be used by applicants for the intake assessment ofnovel. The intake estimation depends to a large extent on the usesand conditions of use of the novel food. These conditions shouldtherefore be chosen so, that they would not pose any risk to thetarget population. In addition, they should be chosen in a realisticmanner, i.e. it should be considered that restrictions of use couldrealistically be adhered to.
For all aspects to be covered in the application dossier counts thatif the dossier presents the data in biased way, credibility of thesubmission is affected, and hence the dossier is definitively nota one.
As indicated in the earlier paragraphs, a good dossier on productsderived from algae cell culture should have detailed informationon the history of safe food use in a third country, which should beconfirmed by compositional data and experience of continued usefor at least 25 years in the customary diet of a significant numberof people in at least one third country.
The information requirements for evaluation of notificationsfor traditional foods pertain to compositional data, the extentof consumption of the traditional food in a non-EU country orcountries, and the information on safe use.
Applicants may request confidential treatment of certaininformation submitted under the Novel Food Regulation wheredisclosure of such information may harm their competitiveposition. In their application for confidentiality, applicants shallindicate which parts of the information provided they wish to betreated as confidential and provide all the necessary and verifiableinformation to substantiate their request for confidentiality. TheCommission will then examine the submitted information andinform the applicant of its position.
After being informed of the Commission's position on the request,applicants may withdraw their application within three weeks,during which the confidentiality of the information provided shallbe observed. After expiry of the 3 week period and if the applicanthas not withdrawn the application, and in case of disagreement,the Commission shall decide which parts of the information are toremain confidential and, in case a decision has been taken, notifythe Member States and the applicant accordingly.
Confidentiality shall not apply to the following information: (a) thename and address of the applicant; (b) the name and descriptionof the novel food; (c) the proposed conditions of use of the novelfood; (d) a summary of the studies submitted by the applicant; (e)the results of the studies carried out to demonstrate the safety ofthe food; (f) where appropriate, the analysis method(s); (g) anyprohibition or restriction imposed in respect of the food by a thirdcountry.
Under the Novel Food Regulation (Article 26) the applicant may request that newly developed scientific evidence or scientific data supporting the application shall not be used for the benefit of a subsequent application during a period of five years from the date of the authorisation of the novel food without the agreement of the initial applicant. In that case the applicant needs to submit in the application appropriate and verifiable information supporting the data protection request.
Data protection is granted by the Commission (Article 27(1) of the Novel Food Regulation) where the following conditions are met: (a) the newly developed scientific evidence or scientific data was designated as proprietary by the initial applicant at the time the first application was made; (b) the initial applicant had exclusive right of reference to the proprietary scientific evidence or scientific data at the time the first application was made; and (c) the novel food could not have been assessed by the Authority and authorised without the submission of the proprietary scientific evidence or scientific data by the initial applicant. However, the initial applicant may agree with a subsequent applicant that such scientific evidence and scientific data may be used. Data protection is not applicable to traditional foods from third countries.
The following general recommendations will help a potentialNovel Food applicant:
As a general information the cost of consultancy may range from50.000 € to 200.000 €, depending on the service provider. It mayalso be very helpful to consider indicative prices per batch of someof the most relevant toxicity assays:
TOXICITY ASSAY | APROX. COST (EURO) | LEAD TIME (WEEKS) |
---|---|---|
In vitro micronucleus assay OECD/GLP standard | 41.250 | 4 |
Ames GLP | 3.650-4.500 | 12 |
In vitro chromosomal aberration | 9.031 | 10 |
Sub chronic toxicity OECD/GLP | 91.300-172.652 | 40 |
Acute toxicity | 780-1.100 | 4 |
Alergenicity | 25.000-45.000 | 4 |
When considering a tentative budget applicant must have in mindthe number of batches used per assay.Algae derived novel foods have been approved since 1997, theseexamples may be useful for future applicants (EFSA 2006, 2014).
European Food Safety Authority. Application of Systematic ReviewMethodology to Food and Feed Safety Assessments to SupportDecision Making. EFSA Journal 2010; 8, 1637
European Food Safety Authority. Use of the EFSA ComprehensiveEuropean Food Consumption Database in Exposure Assessment.EFSA Journal 2011, 9, 2097
Efsa Panel on Nutrition, Dietetic Products and Allergies (NDA) et al.Guidance on the Preparation and Presentation of an Applicationfor Authorization of a Novel Food in the Context of Regulation (EU)2015/2283. EFSA Journal 2016, 14, 4594 (http://www.efsa.europa.eu/en/efsajournal/pub/4594)
Efsa Panel on Nutrition, Dietetic Products and Allergies (NDA) et al.Guidance on the preparation and presentation of the notificationand application for authorisation of traditional foods from thirdEFSA Journal 2016, 14,:4590
European Food Safety Authority. Statement of the Scientific Panelon Dietetic Products, Nutrition and Allergies on a request from theCommission related to the addition of DHA-rich oil from microalgae to an extended range of foods. http://www.efsa.europa.eu/science/nda/nda_statements/catindex_en.html 2006
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA).Scientific Opinion on the extension of use for DHA and EPA-richalgal oil from Schizochytrium sp. as a Novel Food ingredient. EFSAJournal 2014;12(10):3843
EFSA. Administrative guidance on the submission of applicationsfor authorisation of a novel food pursuant to Article 10 ofRegulation (EU) 2015/2283 European Food Safety Authority EFSASupporting publication 2018:EN-1381.
Report of Conseil Superieur D’Hygiene Publique De France of 30 September 1986 authorizing use as food of blue coloring extract by water from Spirulina
JRC Technical Report EUR 27425 EN “Provision of scientific and technical support with respect to the classification of extracts/ concentrates with colouring properties either as food colours (food additives falling under Regulation (EC) No 1333/2008) or colouring foods” 2015
This report on "Algae as sources for Novel Foods – EABA White Paper", (2020nov27)" has been drafted by Dr. Graziella Chini-Zittelli (IBE-CNR), Mr. Carlos Unamunzaga (Fitoplancton Marino), Mr. Silvio Mangini (Archimede Ricerche), Dr Jean-Paul Cadoret (EABA President) and Dr Vitor Verdelho (A4F / EABA General Manager) on behalf of EABA. The information and conclusions in this report should not be treated as binding on the individuals, companies and organisations involved. The positions and recommendations listed hereafter do not necessarily reflect the official position either of the EABA or of the Organizations involved. The EABA does not guarantee the accuracy of the status included in this report and by no means should they be considered as official recommendations. Neither the EABA nor any person acting on the EABA, or the Organizations represented may be held responsible for the use which may be made of the information contained herein. The individuals concerned have offered their views in a personal capacity.
Algae are a crop?
Yes, algae are new crops, food and nutraceutical sources.
Why are you talking about new foods?
Need to Find Innovative Resources for a more Sustainable, Safe and Nutritious feeding.
Algae are Novel Food?
Yes, if not consumed to any significant degree in the EU prior to May 1997 (when the first Novel Foods legislation entered into force).
GMO algae are Novel Food?
No GMOs have separate legislation (Regulation EC 1829/2003).
Traditional algae widely consumed as food in third countries are “new foods” in Europe?
Yes, algae fermentation and algae biomass transformation are industry, the secondary sector.
Why is the EU Commission revising the legislation for novel foods?
To increase the efficiency of the authorisation procedure, enable a quicker delivery of safe,innovative food to the market and remove unnecessary barriers to trade, while still ensuring food safety.
What are the main changes being introduced?
Centralised authorisation system (EU); EFSA responsible for carrying out the risk assessment on the novel food applications; data protection provisions; simpler procedure for traditional foods from third countries with demonstrated history of safe use.
What are the requirements for a novel food to be authorised for use inthe EU?
Do not present a danger to public health, are not nutritionally disadvantageous when replacing a similar food and are not misleading to the consumer. They must undergo a scientific assessment prior to authorization.
Are there any Algae novel food applications in the pipeline at the moment?
Any applications not finalised under the current rules by 1 January 2018 (when the new regulation comes into effect) will be decided under the new regulation. An example of pending applications is the marine "Nannochloropsis gaditana” as food ingredients.
Can Member States ban / approve a novel food independently of the reasons?
No. Once a foodstuff is approved formarketing in the EU, it can be sold inany Member State. If a food is foundto pose any risk to consumers, theCommission can immediately suspend itsauthorisation for marketing in the EU.
Phycocyanin from Spirulina and otheralgae is novel food?
Spirulina water extract is a coloring food according to French legislation (Cons Hyg France 1986) and in compliance with technical requirements described in JRC report about classification of extracts/ concentrates with coloring properties either as food colors or coloring foods (JRC 2015)Pure Phycocyanin is not reported in the positive list of food colors (Additives, Reg. (EC) 1333/2008), is not in the current Union List nor in the Novel Foods Catalog, therefore could be considereda Novel Food.
Dunaliella (or ß-carotene fromDunaliella) requires novel food statuseven if is consumed in Japan for morethan 20 years?
Yes because not significantly used in EUbefore 1997. An applicant can requireauthorization as “traditional foodsfrom third countries” producing all datanecessary to demonstrate its safe use.
EU microalgae world to face moreconstraints than American or Eastern?
Yes. Major challenges: unfavorableclimatic conditions for low-cost extensiveproduction; insufficient domestic demandand the complexity of the EU Novel Foodregulation.
Is the EU regulation more severe andrestrictive than US (GRAS) one?
Compared to US, European regulationsare more stringent or precautionary.As there is no legal distinction between“novel” and other foods in the UnitedStates, exporters may be unaware that afood which is currently lawfully marketedin the US may fall within one of the newcategories established by Regulation2015/2283.
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